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NDC 00363-0022-72 cimetidine 200 mg/1 Details

cimetidine 200 mg/1

cimetidine is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is CIMETIDINE.

MedlinePlus Drug Summary

Cimetidine is used to treat ulcers; gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the food pipe (esophagus); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome. Over-the-counter cimetidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach. Cimetidine is in a class of medications called H2 blockers. It decreases the amount of acid made in the stomach.

Related Packages: 00363-0022-72
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cimetidine

Product Information

NDC	00363-0022
Product ID	0363-0022_876d2141-a51c-4055-a95d-3afdc7e57588
Associated GPIs	49200010000305
GCN Sequence Number	011665
GCN Sequence Number Description	cimetidine TABLET 200 MG ORAL
HIC3	Z2D
HIC3 Description	HISTAMINE H2-RECEPTOR INHIBITORS
GCN	46750
HICL Sequence Number	004518
HICL Sequence Number Description	CIMETIDINE
Brand/Generic	Generic
Proprietary Name	cimetidine
Proprietary Name Suffix	acid reducer
Non-Proprietary Name	Cimetidine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	CIMETIDINE
Labeler Name	Walgreen Company
Pharmaceutical Class	Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075285
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0022-72 (00363002272)

Pricing Information	N/A
NDC Package Code	0363-0022-72
Billing NDC	00363002272
Package	1 BOTTLE in 1 CARTON (0363-0022-72) / 60 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date	2010-04-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7087f4bb-992b-4680-a9a7-452ce74eed2d Details

Active ingredient (in each tablet)

Cimetidine 200 mg

Purpose

Acid reducer

Uses

•: relieves heartburn associated with acid indigestion and sour stomach
•: prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to cimetidine or other acid reducers

Do not use

•: if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
•: with other acid reducers

Ask a doctor before use if you have

•: frequent chest pain
•: frequent wheezing, particularly with heartburn
•: unexplained weight loss
•: nausea or vomiting
•: stomach pain
•: had heartburn over 3 months. This may be a sign of a more serious condition.
•: heartburn with lightheadedness, sweating or dizziness
•: chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
•: kidney disease
•: liver disease

Ask a doctor or pharmacist before use if you are taking

•: a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

•: you need to take this product for more than 14 days
•: stomach pain continues
•: your heartburn continues or worsens

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

•: adults and children 12 years and over:
•: to relieve symptoms, swallow 1 tablet with a glass of water
•: to prevent symptoms, swallow 1 tablet with a glass of water right before or any time up to 30minutes before eating food or drinking beverages that cause heartburn
•: do not take more than 2 tablets in 24 hours
•: children under 12 years: ask a doctor

Other information

•: store at 20°-25°C (68°-77°F)

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tagamet HB® 200 active ingredient

Cimetidine 200

CIMETIDINE TABLETS USP, 200 mg / ACID REDUCER

Just one tablet relieves & prevents heartburn & acid indigestion

Take before, during or after a meal

60 TABLETS (60 DOSES)

ACTUAL SIZE

INGREDIENTS AND APPEARANCE

CIMETIDINE ACID REDUCER

cimetidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0022
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD)	CIMETIDINE	200 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	L022
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0022-72	1 in 1 CARTON	04/14/2010
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075285	03/27/2001

Labeler - Walgreen Company (008965063)

Revised: 5/2021

Document Id: 876d2141-a51c-4055-a95d-3afdc7e57588

Set id: 7087f4bb-992b-4680-a9a7-452ce74eed2d

Version: 6

Effective Time: 20210520